Significant Changes on the Horizon to the Limitations on Subcontracting
Client Alert | 1 min read | 01.14.15
On December 29, 2014, the Small Business Administration issued long overdue proposed amendments to its regulations (with 60 days for comments) to implement many of the provisions of the National Defense Authorization Act of 2013, most notably with a complete overhaul of the calculation of the limitations on subcontracting. Additional proposed revisions include: greater specificity to the identity of interest affiliation test; exemptions from affiliation for small business joint venture members and "similarly situated" subcontractors; a new recertification requirement for mergers/acquisitions occurring after proposal submission but prior to award; changes to the nonmanufacturer rule; and a new reporting mechanism and expanded sanctions related to subcontracting plan compliance.
Insights
Client Alert | 4 min read | 04.10.25
Hikma and Amici Curiae Ask Supreme Court to Revisit Induced Infringement by Generic “Skinny Labels”
In Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., C.A. No. 20-1630 (D. Del.), brand manufacturer Amarin brought an induced infringement claim against Hikma’s generic icosapent ethyl product, which lists Amarin’s Vascepa® as the reference listed drug. Vascepa was originally approved by the U.S. Food and Drug Administration (“FDA”) to treat severe hypertriglyceridemia, and later, Amarin obtained patents and approval for Vascepa as a treatment to reduce cardiovascular risk in certain patient populations. Hikma’s Abbreviated New Drug Application (“ANDA”) for generic icosapent ethyl included a Section viii statement that Hikma was not seeking approval for the patented cardiovascular indication along with a “skinny label” that included only the indication for severe hypertriglyceridemia.
Client Alert | 1 min read | 04.09.25
Client Alert | 12 min read | 04.09.25
Client Alert | 4 min read | 04.07.25
